1. Field of the Invention
The present invention relates, in general, to emergency medical kits and pre-use checks and, more particularly, to emergency medical kits and pre-use checks associated with sedation and analgesia systems.
2. Description of the Related Art
A sedation and analgesia system has been developed to provide patients undergoing painful, uncomfortable or otherwise frightening (anxiety inspiring) medical or surgical procedures with a means for receiving sedative, analgesic, and/or amnestic drugs safely in a way that reduces the risk of overmedication with or without the presence of a licensed anesthesia provider. Due to significant advances in technology, the sedation and analgesia system may be safer for use in hospital and ambulatory environments and may be operated by individuals other than trained anesthesiologists such as, for example, C.R.N.A.'s, trained physicians, or other trained operators. The sedation and analgesia system has gone far to meet the needs of practitioners who are unable to schedule anesthesia providers for every procedure where safe and effective sedation and analgesia could substantially mitigate the effects of fear and pain. The advent of a sedation and analgesia system devoted to these purposes provides these individuals with a drug delivery system integrated into a patient monitoring system that decreases the cognitive and manual workload required with the operation of anesthesia machines, yet keeps the clinician in the loop of patient management. The clinician maintains ultimate decision making responsibility following a “clinician knows best” philosophy. This advanced technology allows for the sedation and analgesia system to be operated at drug level effects less than general anesthesia without an anesthesia provider, providing the patient with a cost-effective and readily available means of sedation, amnesia, and/or analgesia.
Due to the semi-automated nature of the sedation and analgesia system, sedatives, analgesics, and/or amnestics may be administered to patients outside of a hospital environment by non-anesthetist clinicians. Though the flexible use of such a system allows sedation, analgesia, and/or amnesia drugs to be administered in a wide variety of medical environments, many of these environments may not be equipped with the proper equipment and/or procedures to ensure patient safety during a medical emergency. For example, most operating rooms carry in-room suction equipment and they have well-established procedures for ensuring this equipment is ready to use in the event of life-threatening emesis with a high risk of pulmonary acid aspiration; prevention of which requires immediate oral and laryngeal suctioning. Many ambulatory environments where sedation and analgesia may be administered may not have the proper suction apparatus or the procedures for ensuring its immediate availability and proper function.
Similarly, most operating rooms have emergency medical equipment, supplies, and pharmaceutical agents located within close proximity to the procedural rooms. Further, operating rooms have policies and procedures ensuring that these emergency support systems are properly stocked and functional. Many procedure environments outside of the operating room do not stock all of the necessary emergency resuscitation equipment for treatment of sedation and analgesia adverse events, much less, have procedures for ensuring their presence and function. Though Joint Commission on Accreditation of Healthcare Organizations (JCAHO) regulations require a variety of general emergency medical supplies to be present in both hospitals and ambulatory environments, such kits may be large and bulky and may not be tailored to the specific needs of patients experiencing a medical emergency as a result of the delivery of sedative, analgesic, and/or amnestic drugs. The need has therefore arisen for an emergency medical kit in association with quality assurance procedures tailored specifically for medical emergencies involving a sedation and analgesia system.
Further, requiring clinicians to account for each additional emergency medical supply not present in a standard “crash” cart needed for procedures involving a sedation and analgesia system may require a great deal of time, where time between procedures may be at a premium. Supplies for a medical emergency may be present in varying degrees in medical environments outside the operating room, however the need exists for an efficient method and system of ensuring that all the necessary supplies are present to handle a medical emergency resulting from the delivery of sedatives, analgesics, and/or amnestics.
A number of resuscitation kits have been developed, such as those produced by Banyan International Corporation, for placement in a wide variety of locations such as airplanes and hotel lobbies, where such kits contain medical supplies that may be used in the event of a medical emergency. These kits are generally designed for use by a wide variety of individuals with a wide variety of skill levels from lay people who may administer basic first aid to fully trained intensive care physicians. Most existing kits are geared for a wide spectrum of care from first aid and basic life support to advanced cardiac life support (ACLS). When supplies from such kits are used during medical emergencies depleted, disabled, or contaminated supplies may not be replaced, which may result in the subsequent use of a kit that is missing necessary supplies or contains contaminated supplies. Further, there are generally no means to ensure that missing or expired drugs and/or non-functional equipment are replaced, potentially endangering recipients of the expired supplies. The need has therefore arisen for a method of ensuring that emergency medical supplies are present in the event of a medical emergency involving a sedation and analgesia system, that equipment is present and in full working order, and that emergency drugs are available and have not expired.
Medical kits designed for pulmonary and cardiac arrest are often found in hospital wards, where such kits generally carry a vast array of equipment and are mounted on wheels due to their large size. Such kits also involve a series of pre-use protocols to ensure that supplies contained within the kit are present, in working order, and have not expired. One example of these protocols is a supply checklist, where the checklist contains all of the required equipment and drugs for the kit and where each element of the kit may be checked off as it is determined to be present, functioning, and not expired. Such checklists are generally performed following the use of the “crash” cart and after a pre-determined period of non-use, where expired supplies and depleted supplies are replaced before use of the kit is permitted. A further required procedure for many such kits involves the use of tamper evident seals, where a tamper evident seal may be placed on the kit following the restocking of the kit and the checklist procedure. Many tamper evident seals are marked with the date the checklist procedure was performed and must be broken for the kit to be used. Such pre-use checks have been effective in maintaining the quality of large in-house medical kits, however the large size of such kits generally limits their presence to a single kit per ward, and the vast quantity of equipment and drugs present in such kits may make finding needed supplies an inefficient and time consuming process. The need has therefore arisen for a readily available emergency medical kit that contains medical supplies specifically tailored to medical emergencies involving a sedation and analgesia system, where excess supplies unrelated to medical emergencies involving the delivery of sedatives, analgesics, and/or amnestics may be eliminated. The need further exists for emergency kits designed for, and integrated with, a sedation and analgesia system that has pre-use checks and procedures to ensure that required medical supplies are present, in working order, and have not expired.
Though JCAHO and other regulatory agencies use a number of policies and procedures to ensure that emergency medical kits employed in hospitals and ambulatory medical environments are present and functional, such policies and procedures do not extend to emergency medical kits specifically designed for a sedation and analgesia system. The need has therefore arisen for policies and procedures incorporated into a sedation and analgesia system that ensure the proper functionality of the system, that the necessary components of the system are present, and that emergency medical supplies associated with the system are present, functioning, and not expired. Due to the potentially time consuming nature of checking all components of a sedation and analgesia system and emergency medical supplies associated with such a system, the need has further arisen for pre-use checks and procedures that are efficient yet comprehensive.